Proposed Enhancements to Adverse Event Reporting for Medical Devices - Industry

Closes 1 Dec 2020

Opened 23 Sep 2020

Overview

The Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA has issued this consultation paper as part of the Government’s reform program

The purpose of this consultation paper is to seek feedback on proposals that aim to enhance Australia’s medical device adverse event reporting system.

Why We Are Consulting

A range of reviews and inquiries have identified that the existing adverse event reporting system can be improved further. Hence, this consultation seeks feedback on five proposals that aim to enhance the adverse event reporting system and improve access to safety information related to medical devices.

We invite you to provide your feedback by completing our online survey (click on the link below) or you can make a submission directly to the Department via post or email at the following addresses:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

devicereforms@tga.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

Events

  • Webinar -1 Proposed enhancement to adverse event reporting for medical devices: Industry

    From 19 Oct 2020 at 11:00 to 19 Oct 2020 at 11:30

    This webinar aims to provide targeted information to sponsors, manufacturers and distributors of medical devices about the proposed enhancements to adverse event reporting.
    The focus of this webinar will be on proposal 1, 2, 4, and 5.

  • Webinar -2 Proposed enhancement to adverse event reporting for medical devices: Consumers

    From 26 Oct 2020 at 14:00 to 26 Oct 2020 at 14:30

    This webinar aims to provide targeted information to consumers of medical devices about the proposed enhancements to adverse event reporting.
    The focus of this webinar will be on proposal 1, 2, 4, and 5.

  • Webinar -3 Proposed enhancement to adverse event reporting for medical devices: Industry and Consumers

    From 2 Nov 2020 at 14:00 to 2 Nov 2020 at 14:30

    This webinar aims to provide information about a proposal to introduce a new program whereby the TGA would actively inspect and/or audit medical device sponsors’ systems for how they identify, report and manage their post market reporting obligations.

Audiences

  • Aboriginal and Torres Strait Islander People
  • Seniors
  • Men
  • Women
  • Carers and guardians
  • Families
  • Parents
  • Young people
  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Contracted Service Providers
  • Aged care service providers
  • Aged care workforce
  • Aged care professionals
  • Medical Devices & IVDs

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Legislation
  • Regulatory policy
  • Strategic Policy
  • Policy Development